Syris v900L, Directions For Use Manual

Page 1: ...v900LTM Visualization System Directions for Use v900L DFU Doc 9001_1 TM Scientific ...

Page 2: ...nds www cepartner4u eu Syris Scientific and v900L are trademarks of Syris Scientific LLC All contents of this manual are the proprietary copyright property of Syris Scientific LLC and are subject to change at the discretion without notification by the manufacturer No parts of this manual may be copied transmitted or disseminated to other parties without express written permission from the manufact...

Page 3: ... 8 v900L Component Parts 10 Charging the Battery 11 Installing Removing the Battery 12 Control Module indicator lights and states 13 Wearing the Device Adjusting For Use 13 Turning the Device On Off and Adjustments 15 Headband Replacement 16 MAINTENANCE SUPPORT 16 Handling and Storage 17 Cleaning 17 v900L Specifications 18 v900L Standards 19 v900L Parts and Accessories Ordering Information 19 Serv...

Page 4: ...r field of view Safety Clinical WARNING The v900L is for vision enhancement use by a qualified medical professional during dermal procedures Read all Warnings Cautionary Statements and Directions in their entirety before operating the v900L Conventions Used Symbols This manual and device packaging uses internationally accepted conventions in describing information requiring further attention by th...

Page 5: ... care Temperature limitation Power on off IEC 61140 Class II Electrical Appliance Patient and User Safety WARNINGS The v900L is for use by qualified medical personnel only Qty Keep dry Quantity Dispose of accordingly Allowable humidity range Allowable temperature range MRI Unsafe DO NOT plug AC power supply into control module ...

Page 6: ...ttery from the v900L Control Module in an oxygen enriched environment DO NOT operate the system in a flammable or explosive atmosphere Unplug the VTS1000 PS Power Supply from the AC main wall outlet to remove main power DO NOT position VTS1000 Power Supply and VTS1000 Charger Base where it is difficult to disconnect the Power Supply from the AC main wall outlet DO NOT modify the v900L equipment wi...

Page 7: ...T use ammonia based cleaners DO NOT immerse any component of the v900L including battery charger control box cable or batteries in water or other liquids DO NOT sterilize or autoclave the v900L or its accessories Dispose of batteries and accessories per your facility policy or local regulations The v900L and its accessories are not field serviceable Do not attempt to repair or use a malfunctioning...

Page 8: ...the v900L Only use provided power supply Control Module and cable with this system DO NOT touch the battery contact of the VTS1000 Battery and the patient at the same time Fire Cautions DO NOT block any opening of the system Doing so may cause overheating of the Illuminator Module Avoid operating the system in dusty environments Setup Use of Device Unpacking Inspection Please ensure your v900L Vis...

Page 9: ...S1000 CHARGER 1 5 Carrying Case 1 Control Module Belt 1 Carrying Case Strap 1 6 Directions For Use DFU v900L DFU 1 v900L DFU Intl 1 Includes charger base and power supply Included in carrying case One DFU included 1 v900L 5 Carrying Case Belt Strap Power Supply 6 DFU V900L DFU 2 Control Module V900L 70 4 Battery Charger System VTS1000 Charger 3 Battery VTS1000 BAT ...

Page 10: ...1 v900L Illuminator and Visi Shield WARNING To avoid the risk of electrical shock inspect the battery charger cable and plug for damage before use Do not use the v900L or accessories if damaged Use only Syris supplied battery charger control box cable battery and accessories In the event of visible damage do not use and contact Syris for replacement VTS1000 Power Supply is a part of the v900L syst...

Page 11: ... appropriate AC adapter and ensure that the AC adapter snaps securely into Power Supply Prior to initial use plug the power supply into an approved 100 240 VAC 50 60Hz wall outlet Insert battery into Charger Base and the indicator light begins to blink green indicating that charging has begun Charging is complete when the indicator light on the charger base unit turns solid green approximately fiv...

Page 12: ...trol Module Press down the blue tab on the top of the Battery and pivot the battery into the Control Module Release the blue tab making sure the Battery securely locks into place See Figure 3 To remove the Battery press down the blue tab and pivot the Battery out of the Control Module Note After inserting Battery into Control Module attach Control Module onto belt Make sure belt is secure on the b...

Page 13: ... Orange Less than 30 minutes of operation time at full power remain Red Less than 10 minutes of operation time at full power remain When the battery indicator is red the unit will emit 3 tones every 30 seconds until the unit automatically shuts down Time is typical Reducing the light intensity to the low setting will extend the operation time by approximately 33 v900L Wearing the Device Adjusting ...

Page 14: ...that the top strap of the head basket be adjusted to allow the rear section of the head basket to fit below the occipital lobe 2 Position the v900L on your head ensuring that the front of the headband sits comfortably above your eyebrows and the rear of the headband sits at the base of the occipital lobe If the head basket sits too high or too low on your head repeat step 1 3 Adjust the position o...

Page 15: ... directly into the Illuminator Module Turning the v900L On Off and Adjustments With a charged battery installed in the Control Module and the illuminator cable connected to the Control Module press the blue power button once to turn the v900L on with its brightest light An audible beep and a green LED will indicate the unit is on Push the button a second time to reduce light intensity indicated by...

Page 16: ...e call Syris Scientific at 207 657 7050 Monday Friday 8 00 a m to 5 00 p m EST or visit the website www syrisscientific com Syris Scientific Headband Replacement The Headband Pads may be cleaned or replaced as desired To maintain the comfort level designed into the v900L and for sanitary purposes it is recommended that the comfort Headband pads be replaced monthly Purchase additional Headband Pads...

Page 17: ... users DO NOT apply cleaner directly onto device or its components DO NOT use any product containing ammonia The v900L head basket can be wiped down using any common non abrasive chlorine or alcohol based cleaners found in a medical environment The v900L is an optical instrument and the optical surfaces need to be kept clean for optimum image quality It is recommended to clean the Visi Shield with...

Page 18: ...ounds Working distance with 3 Lens 14 inches with 4 Lens 10 inches with 5 Lens 8 inches Illumination wavelength 400 700 nanometers Battery type Sealed 7 4V lithium ion Battery run time 240 minutes 4 hours typical Battery charge time 300 minutes 5 hours typical Brass Cellulose Triacetate Exposed materials Glass Gold Nickel Phosphor Bronze Stainless Steel Battery charger input voltage 100 240 VAC 50...

Page 19: ...tor v900L 20 Upper Cable v900L 30 Visi Shield 3 Lens v900L 40 Visi Shield 4 Lens v900L 50 Visi Shield 5 Lens v900L 70 Control Module v900L 80 Replacement Comfort Headbands 10 sets VTS1000 BAT Battery Additional VTS1000 CHARGER Battery Charger Base Power Supply v900L DFU Directions For Use v900L DFU Intl Directions For Use International Note Manuals are available in English French German Italian an...

Page 20: ...the Warranties the Customer shall promptly notify Syris of a Warranty Claim If the Customer does not provide notice of Warranty Claim within the Warranty Period the Customer shall not have any right to claim that the Equipment does not comply with the Warranties The Customer shall inspect the Equipment promptly after delivery to the Customer and promptly notify Syris of any alleged breach of any W...

Page 21: ...d 50 60Hz be that of a typical commercial or Magnetic Field hospital environment EN IEC 61000 4 8 Emissions Equipment and Systems that are NOT Life supporting Immunity Test EN IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF 3 Vrms V1 Vrms EN IEC 61000 4 6 150 kHz to 80 MHz Portable and mobile communications equipment should be separated from the v900L by no ...

Page 22: ...ed below The customer or the user of the v900L should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The v900L uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The v...

Page 23: ...23 Directions For Use v900L NOTES ...

Page 24: ...Thank you for purchasing Syris Products Syris Scientific LLC 22 Shaker Rd P O Box 127 Gray Maine 04039 207 657 7050 TEL 207 657 7051 FAX WWW SYRISSCIENTIFIC COM M 13251R1 ...